MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-07-21 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[4645983]
Ous mdr - it was reported that the device is not capturing properly. No details available at the moment. No adverse patient side effects were reported.
Patient Sequence No: 1, Text Type: D, B5
[17813015]
Upon receipt, the external pacemaker was inspected. Despite the damaged case, which was repaired, the device did not show any deviation during analysis. No indication which might have contributed to the clinical observation was revealed. The visual, mechanical and functional analysis revealed no anomalies and no material or manufacturing deviation was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2014-002440 |
| MDR Report Key | 3947446 |
| Report Source | 01,07 |
| Date Received | 2014-07-21 |
| Date of Report | 2014-07-08 |
| Date Mfgr Received | 2014-08-04 |
| Device Manufacturer Date | 2010-10-05 |
| Date Added to Maude | 2014-07-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REOCOR D |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2014-07-21 |
| Model Number | 365529 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-21 |